9 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PATIENT MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
NexxZr™ T / D-100-35-NT-B200-SD
FDA UDI
SAGEMAX BIOCERAMICS, INC·00842271112873·
CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET)
FDA 510(k)
FDA Class 1
·General Hospital
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
DORMA 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code BZD·March 16, 2022
530G INSULIN PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·October 1, 2014
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 29, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·June 16, 2011
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024